Cleared Traditional

K974903 - GAS MODULE II

K974903 is the FDA 510(k) clearance for GAS MODULE II by Datascope Corp.. It is a Class 2 Anesthesiology device (product code CBS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K974903 · Datascope Corp. · Anesthesiology device
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Mar 1998
Decision
72d
Days
Class 2
Risk

K974903 is an FDA 510(k) clearance for the GAS MODULE II, MODEL 0998-00-0143. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datascope Corp. devices

Submission Details

510(k) Number K974903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1997
Decision Date March 13, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 140d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 7
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K974903.
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
K950101 · Marquette Electronics, Inc. · Mar 1995
AS/3 AIRWAY MODULE
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CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · Datex Division Instrumentarium Corp. · Jun 1991
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · Hewlett-Packard Co. · Jan 1990
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · Draeger Medical, Inc. · Oct 1987
NORMAC ANESTHETIC AGENT MONITOR
K832113 · Datex Division Instrumentarium Corp. · Sep 1983